Warning to Women who Smoke

Do not use Natazia if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What is Natazia?

Natazia is a birth control pill. It contains two female hormones, an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in your body.

How well does Natazia work?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results of two clinical studies, 1 to 2 women out of 100 women may get pregnant during the first year they use Natazia.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

How do i take Natazia?

Take one pill every day at the same time. Take the pills in the order directed on the blister pack.

Do not skip pills or delay taking your pill by more than 12 hours. If you miss pills (including starting the pack late), you could get pregnant. The more pills you miss, the more likely you are to get pregnant.

If you have trouble remembering to take Natazia, talk to your healthcare provider about how to make pill-taking easier, or about using another method of birth control.

You may have spotting or light bleeding when you first take Natazia. Spotting or light bleeding is normal at first.

You may feel sick to your stomach (nauseous), especially during the first few months that you take Natazia. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea doesn't go away, call your healthcare provider.

If you vomit or have diarrhea within 4 hours of taking your pill, follow the instructions for "What Should I Do if I Miss any Pills."

Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

Before you start taking Natazia

Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on the blister pack.

Look at your Natazia blister pack. The blister pack has four rows of 7 pills each, for a total of 28 pills. Find:

where on the pack to start taking your pills

in what order to take the pills

Each NATAZIA blister pack has 28 pills

2 dark yellow pills with hormones, for Days 1 and 2

5 medium red pills with hormones for Days 3-7

17 light yellow pills with hormones for Days 8-24

2 dark red pills with hormones for Days 25 and 26

2 white pills without hormones for Days 27 and 28

After taking the last white pill (day 28) of the blister pack, start taking the first dark yellow pill from a new blister pack the very next day whether or not you are having your period.

Be sure to have ready at all times another kind of birth control (such as condoms and spermicides) to use as a back-up in case you miss pills.

It is not uncommon to miss a period. However, if you miss 2 periods in a row or feel like you may be pregnant, call your healthcare provider. If you are pregnant, you should stop taking Natazia.

When to start Natazia

If you start taking Natazia and you did not use a hormonal birth control method before:

Take the first dark yellow pill on the first day (Day 1) of your natural menstrual cycle. The first day of your menstrual cycle is the first day you start spotting or bleeding.

Use non-hormonal back-up contraception such as a condom and spermicide for the first 9 days that you take Natazia.

If you start taking Natazia and you are switching from a combination hormonal method such as:

another pill

vaginal ring

patch

Take the first dark yellow pill on the first day of your period. Do not continue taking the pills from your previous birth control pack. If you do not have a period, contact your healthcare provider before you start Natazia.

If you previously used a vaginal ring or transdermal patch, you should start using Natazia on the day the ring or patch is removed.

Use a non-hormonal back-up method such as a condom and spermicide for the first 9 days you take Natazia.

If you start taking Natazia and you are switching from a progestin-only method such as a:

progestin-only pill

implant

intrauterine system

injection

Take the first dark yellow pill on the day you would have taken your next progestin-only pill or on the day of removal of your implant or intrauterine system or on the day when you would have had your next injection.

Use a non-hormonal back-up method such as a condom and spermicide for the first 9 days you take Natazia.

What should i do if i miss any pills

If you forgot to start a new blister pack, you may already be pregnant. Use back-up contraception (such as condoms and spermicides) anytime you have sex. Call your healthcare provider if you are unsure whether you are pregnant.

Do not take more than 2 pills in one day. On the days you take 2 pills to make up for missed pills, you may feel a little sick to your stomach (nauseous).

If you start vomiting or have diarrhea within 4 hours of taking your pill, take another pill of the same color from your extra blister pack.

If you are less than 12 hours late taking your pill

Take your pill as soon as you remember

Take the next pill at the usual time

You do not need to use back-up contraception

If you miss ONE PILL for more than 12 hours

Days 1-17

Take your missed pill immediately

Take your next pill at the usual time (you may have to take two pills that day)

Use back-up contraception for the next 9 days

Continue taking one pill each day at the same time for the rest of your cycle

Days 18-24

Do not take any pills from your current blister pack and throw the pack away

Take Day 1 pill from a new blister pack

Use back-up contraception for the next 9 days

Continue taking one pill from the new blister pack at the same time each day

Days 25-28

Take your missed pill immediately

Take your next pill at the usual time (you may have to take two pills that day)

No back-up contraception is needed

Continue taking one pill each day at the same time for the rest of your cycle

If you miss two pills in a row

Days 1-17 (if you miss the pills for Days 17 and 18, follow the instructions for Days 17-25 instead)

Do not take the missed pills. Instead, take the pill for the day on which you first noticed you had missed pills.

Use back-up contraception for the next 9 days

Continue taking one pill each day at the same time for the rest of your cycle

Days 17-25 (if you miss the pills for Days 25 and 26, follow the instructions for Days 25-28 instead)

Do not take any pills from your current blister pack and throw the pack away

Take Day 3 pill from a new blister pack

Use back-up contraception for the next 9 days

Continue taking one pill from the new blister pack at the same time each day

Days 25-28

Do not take any pills from your current blister pack and throw the pack away

Start a new pack on the same day or start a new pack on the day you usually start a new pack

No back-up contraception is needed

Continue taking one pill from the new pack at the same time each day, for the rest of your cycle

You may already be pregnant or COULD BECOME PREGNANT if you had sex on the days after the pills were missed. The more pills missed and the closer they are to the end of the cycle, the higher the risk of a pregnancy. You should call your doctor or healthcare provider if you are unsure whether you are already pregnant.

If you are still not sure of what to do about the pills you have missed:

Call your healthcare provider

Use back-up contraception (such as condoms and spermicides) anytime you have sex and keep taking 1 pill each day

Who Should Not Take Natazia?

Your healthcare provider will not give you Natazia if you have:

Ever had breast cancer or any cancer that is sensitive to female hormones

Liver disease, including liver tumors

Ever had blood clots in your arms, legs, or lungs

Ever had a stroke

Ever had a heart attack

Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart

An inherited problem with your blood that makes it clot more than normal

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy).

What else should i know about taking Natazia

Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

Do not skip any pills, even if you do not have sex often.

If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:

Think you are pregnant

Miss one period and have not taken your birth control pills according to directions

Miss two periods in a row

Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Natazia, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

Tell your healthcare provider about all medicines and herbal products that you take. You should not choose Natazia as your birth control pill if you take carbamazepine, phenytoin, rifampicin or St. John's wort, because these medicines may make Natazia ineffective. Some other medicines and herbal products may make birth control pills less effective, including:

Barbiturates

Bosentan

Felbamate

Griseofulvin

Oxcarbazepine

Topiramate

Consider using another birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms and a spermicide, until you check with your healthcare provider.

What are the most serious risks of taking birth control pills

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.

It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

Legs (deep vein thrombosis)

Lungs (pulmonary embolus)

Eyes (loss of eyesight)

Heart (heart attack)

Brain (stroke)

A few women who take birth control pills may get:

High blood pressure

Gallbladder problems

Rare cancerous or noncancerous liver tumors

All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

Persistent leg pain

Sudden shortness of breath

Sudden blindness, partial or complete

Severe pain in your chest

Sudden, severe headache unlike your usual headaches

Weakness or numbness in an arm or leg, or trouble speaking

Yellowing of the skin or eyeballs

What are the common side effects of birth control pills

The most common side effects of birth control pills are:

Spotting or bleeding between menstrual periods

Nausea

Breast tenderness

Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

Acne

Less sexual desire

Bloating or fluid retention

Blotchy darkening of the skin, especially on the face

High blood sugar, especially in women who already have diabetes

High fat levels in the blood

Depression, especially if you have had depression in the past.

Call your healthcare provider immediately if you have any thoughts of harming yourself.

Problems tolerating contact lenses

Weight changes

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

Do birth control pills cause cancer

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What should i know about my period when taking Natazia

Irregular vaginal bleeding or spotting may occur while you are taking Natazia. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider.

Also, your menstrual period while using oral contraceptives may be shorter and lighter than usual. Some women may not have a menstrual period but this should not be cause for alarm as long has you have taken the pills according to direction.

What if i miss my scheduled period when taking Natazia

It is not uncommon to miss your period. However, if you miss more than two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider checks you to find out if you are pregnant. Stop taking Natazia if you are pregnant.

What if i want to become pregnant

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

General advice about Natazia

Your healthcare provider prescribed Natazia for you. Please do not share Natazia with anyone else. Keep Natazia out of the reach of children.

If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare provider for a more detailed label written for medical professionals.